Learn to Dare! Leiden

NCT06609824 | Recruiting DMC

• 1 other identifier: 2024-02-27-A.M. Klein-V2-5116
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Research shows that many children face anxiety and stress related problems. However, as much as 70-80% of children do not receive help. The aim of this project is to offer a training for children who are hindered by their shyness or fears, so that all children can develop freely without being held back and so that the risk of escalation of fear and stress in the long term can be prevented. In this project the prevention training 'Learn to Dare!' will be offered to children between the ages of 8 and 18 where the long-term outcomes and the program itself will be evaluated for attractiveness and satisfaction. With the evidence-based program 'Learn to Dare!\' children between the ages of 8 and 12 learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. This project aims to adapt the program so that it can be available up to and including 18 years in the future.

Conditions

Childhood Anxiety; Shyness

Keywords

Prevention; Childhood Anxiety; Shyness

Outcome Measures

Primary Outcomes (4)

• Change in anxiety severity in children (SCARED-child)

  The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the children. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.

  During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)

• Change in anxiety severity in children (SCARED-parent)

  The Screen for Child Anxiety Related Disorders (SCARED) will be administered to the parents. Scores on the SCARED range between 0-142. A higher score means higher anxiety levels.

  During baseline 1, baseline 2, post-training, and the follow-ups (6, 12, and 24 months after the training)

• Change in severity of anxiety in children (SCID-parent)

  Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the parents.

  From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).

• Change in severity of anxiety in children (SCID-child)

  Severity of anxiety will be assessed using the Structured Clinical Interview for DSM Disorders (SCID) in combination with the severity index (Clinician Severity Rating) of the Anxiety Disorder Interview Schedule (ADIS-V). The CSR-score is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The SCID will be administered to the children.

  From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).

Secondary Outcomes (1)

• Change in self-efficacy of the children (WIRK-ALL child version)

  From baseline to the end of the training and follow-up (6, 12, and 24 months post-training).

Study Arms (1)

Training Group

EXPERIMENTAL

This arm consists of all participants who receive the training intervention. The purpose is to assess longitudinal effectiveness of the training within all participants.

Behavioral: Leer te Durven!

Interventions

Leer te Durven! BEHAVIORAL

'Leer te Durven!' is an eight-week preventative group training for children between the ages of 8 and 12. This training is evidence-based and is based on the principles of Cognitive Behavioral Therapy. With this program children learn to stand up for themselves in a safe environment, to face the situations that they find exciting and to be more confident in their own abilities. The training consists, among other things, of psychoeducation, exposure, and relaxation.

Training Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cut-off scores of the SCARED: for girls 31 and for boys 27.

You may not qualify if:

• Currently under treatment for anxiety complaints or under treatment in the mental health care system for other internalizing complaints.
• Anxiety problems or comorbid problems that require attention or treatment (including a 6 or higher on the severity index (CSR) of the ADIS and a score above the clinical cut-off on the Child Depression Inventory.)
• Difficulty in understanding the training.

Sponsors & Collaborators

• Leiden University: lead
• Leids Universitair Behandel en Expertise Centrum (LUBEC): collaborator

Study Sites (1)

Leiden University

Leiden, South Holland, 2333AK, Netherlands

RECRUITING

Related Publications (1)

• Simon E, de Hullu E, Bogels S, Verboon P, Butler P, van Groeninge W, Slot W, Craske M, Whiteside S, van Lankveld J. Development of 'learn to dare!': An online assessment and intervention platform for anxious children. BMC Psychiatry. 2020 Feb 11;20(1):60. doi: 10.1186/s12888-020-2462-3.

  PMID: 32046669 BACKGROUND

MeSH Terms

Conditions

Shyness

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Anke M Klein, AS

  Leiden University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke M Klein, AS

CONTACT

+31655111908; a.m.klein@fsw.leidenuniv.nl

Anika Bexkens, AS

CONTACT

+31715276566; a.bexkens@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Inverstigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 24, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)